Senior Scientist Bioassay Development and Quality Control

Senior Scientist Bioassay Development and Quality Control

Location:

Waltham, MA

Opportunity to join a fast-paced Gene Therapy bioanalytical team focusing on potency method development, qualification, QC testing and CRO transfer in a compliant GMP environment. This position will improve analytical capacity for the potency team, allowing more programs to progress efficiently through early phase development. The successful candidate will be responsible for method development for multiple viral and non-viral gene therapies through hands‑on work including method development and optimization, SOP and report writing and providing group presentations.

This is a great opportunity for an energetic and dedicated team player willing to do what it takes to support our goal of releasing critical medicines to patients. Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

We’re an R&D‑driven, AI‑powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

• Responsible for early-stage GMP release testing and maintaining a GMP compliant environment.
• Serve as a subject matter expert (SME) for biological potency assays for viral and non-viral products, define the best scientific approaches and analysis methods for quantitative bioassays.
• Development, qualification and validation and transfer of analytical methods.
• Master Sanofi quality systems providing expertise and coaching to team members.
• Perform analytical support testing, ensuring timely completion and delivery of analytical results with appropriate documentation to support product development during clinical phases.
• Participate in analytical leadership teams for viral and non-viral programs.
• Take an active role in Lab maintenance, organization, GMP and safety compliance.
• Ensure compliant use of electronic notebooks.
• Work in a matrixed environment and interact productively with associates, scientists and management at various levels, both locally and internationally.

• PhD in Biological Sciences or related fields, Master's Degree (MS) will be considered.
• 2+ years of experience in a GMP environment (required)
• 4+ years of relevant industry experience, including gene therapy (preferred)

• Bioassay development experience
• Experience in performing QC release and stability assays
• Aptitude to manage multiple types of quality events including deviations, change controls, lab investigations

• Experience with flow cytometry, FRET-assays, effector function assays, reporter cell lines, PCR analysis and/or ELISA endpoints, DOE approaches where appropriate
• Experience automating cell-based assays
• Comprehensive knowledge of gene therapy analytics including potency and impurity paradigms, knowledge of gene therapy regulatory guidance
• Experience performing analytical support for structure/function and in-process studies
• Knowledge of various approaches to data analysis, strong understanding of relative potency assay analysis including software and regulatory expectations
• Experience in technology transfer to other sites
• Experience with Bio Via products

Bring the miracles of science to life alongside a supportive, future‑focused team. Discover endless opportunities through working with a talented and dedicated team in an integrated environment. Grow your…